# K080198: TSO3 Ozone Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Tso3, Inc.
- Decided: May 30, 2008 after 126 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921243 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990300: Suprashield Express Sterilization Wrap, Allegiance Healthcare Corp. (1999) Summary page 1.

## Indications for use
The TS0 3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use with TSO 3 Ozone Sterilization process.

Source page: https://510kreport.com/device/K080198
Methodology: https://510kreport.com/methodology